FOCUS ON CHANGE CONTROL MANAGEMENT IN UPDATING QMS TO INCLUDE LABELING NEEDS

About the Product
Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.

You’ve read the UDI rule, you’ve updated all of your labels, and you’ve submitted your data. Now, how do you stay in compliance? When implementing new requirements into their Quality Management Systems (QMS), manufacturers must ensure that established change control procedures clearly incorporate the new requirements while maintaining the overall efficiency of the QMS. With the new UDI requirements specific to product labels, device and diagnostic corporations must revisit their change control procedures and integrate the appropriate triggers and control mechanisms into their QMS to ensure continued compliance with the new UDI regulation, as well as the Quality System Regulation and the ISO 13485 standard. In addition, manufacturers also need to recognize and comply with the standards defined by their FDA-accredited Issuing Agency with respect to labeling changes that may require new device identifiers and/or database updates.

• Overview of general change control requirements and processes
• Identification of UDI & Issuing Agency requirements for changing labels
• Strategies for managing the downstream impacts of label changes

Speaker:
Chris Kilander
Regulatory Affairs Manager
Cook Pharmica LLC

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

• Labeling Specialist
• Regulatory Labeling
• Quality Management